prospeCtive study on intensive early rheumatoid arthritis treatment with adalimUmab: induction of REmission and maintenance - 'CURE'A Phase IV multicenter, randomized, double-blind study

OSPEDALE POLICLINICO S. MATTEO0 sitesAugust 30, 2006

Conditionsrheumatoid arthritis MedDRA version: 14.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870 Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

DrugsHUMIRA*SC 2SIR+F 40MG 0,8ML+2T METHOTREXATE*100CPR 2,5MG DELTACORTENE FORTE*10CPR 25MG

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: rheumatoid arthritis
Sponsor: OSPEDALE POLICLINICO S. MATTEO
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 30, 2006

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

OSPEDALE POLICLINICO S. MATTEO

Eligibility Criteria

Inclusion Criteria

•1\. Able and willing to give written informed consent and comply with the requirements of the study protocol.
•2\. Patients with active rheumatoid arthritis diagnosed for at least 6 weeks, but no more than 1 year, according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis
•3\. Patients naïve to treatment with MTX and that have received a prednisone dose ≤ 7,5 mg/d and a total prednisone dose ≤250 mg .
•4\. Swollen joint count (SJC) \> 8 (66 joint count), and tender joint count (TJC) \> 8 (68 joint count) at screening and baseline.
•5\. At screening CRP \> 1\.5 mg/dL (15 mg/L) or ESR ≥ 28 mm/h
•6\. ≥ 1 joint erosion or RF positivity or anti\-CCP positivity
•7\. Age 18\-70 years.
•8\. Use of NSAIDs is permitted if stable for at least 2 weeks prior to baseline.
•9\. For patients of reproductive potential (males and females), use of a reliable means of contraception (e.g. hormonal contraceptive, patch, intrauterine device, physical barrier) throughout study participation.
•10\. Must be willing to receive oral folate.

Exclusion Criteria

•Exclusions related to RA
•1\.Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis or Felty's syndrome). Secondary Sjögren's syndrome or secondary limited cutaneous vasculitis with RA is permitted.
•2\.Functional class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis.
•3\.History of, or current, inflammatory joint disease other than RA (including, but not limited to, gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (including, but not limited to, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or any overlap syndrome).
•Exclusions Related to General Health
•1\.Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) within 12 weeks prior to baseline or planned during the study.
•2\.Pregnancy or breastfeeding.
•3\.Significant and/or uncontrolled cardiac or pulmonary disease (including obstructive pulmonary disease).
•4\.Evidence of significant concomitant disease, including but not limited to, nervous system, renal, hepatic, endocrine or gastrointestinal disorders which, in the investigator's opinion, would preclude patient participation.
•5\.Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection.